Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache
Recruitment status was Not yet recruiting
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Purpose
Headache during fasting is a known entity in the scientific literature. The prevalence of such a headache is high and in a study conducted in Israel was found in 60% of people with a previous predilection for headache. A prior study showed a significant decrease in the incidence of fasting headache using rofecoxib, but the drug has been taken off the market. The goal of this project is to evaluate the efficacy of etoricoxib as treatment taken before the fast- a COX-2 inhibitor with a relatively long half life to prevent fasting induced headache. The study will be a prospective double blind placebo controlled trial using adult volunteers with a history of a fasting headache who will be abstaining from food and drink on Yom Kippur.
The study hypothesis is that treatment with etoricoxib prior to a 25 hour fast will decrease the incidence of fasting headache.
| Condition | Intervention | Phase |
|---|---|---|
|
Headache |
Drug: etoricoxib Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache |
- Incidence of Fasting Headache [ Time Frame: 25 hours after administration ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Healthy Patients, age 18-65, who typically suffer from a Headache while fasting
|
Drug: etoricoxib
120 mg
|
|
Placebo Comparator: B
Healthy Patients, age 18-65, who typically suffer from a Headache while fasting
|
Drug: placebo
placebo
|
Detailed Description:
Fasting is a known trigger for headache. More specifically, headache associated with ritual fasting in compliance with religious edict has been documented and described in the literature. These have been described in Jewish and Muslim ritual fasts, and have been dubbed 'Yom Kippur headache,' and 'First of Ramadan headache' respectively. The incidence of fasting associated headache during the 25 hour fast of Yom Kippur (YK) wherein no food or drink is ingested, has been documented in approximately 40% of participants, but as high as 66% of those prone to headache. (1) A recent study was published in which the authors were able to show a marked reduction in YK headache using rofecoxib 50mg, a Cox 2 specific nonsteroidal anti-inflammatory medication with a relatively long (17 hour) half life. In a placebo controlled double blind randomized trial, in a population with a history of fasting headache, the drug was ingested just prior to the start of the fast. The placebo group had an incidence of headache 65% of the time whereas the treatment group had an incidence of 19%. Headache in the treatment set was also on average milder than in the controls. These results were all significant statistically. (3)
Unfortunately for sufferers of fasting headache, rofecoxib (Vioxx), has been removed from the market and is no longer available.
We therefore propose to conduct a second study using etoricoxib (Arcoxia) - a Cox 2 specific antiinflammatory medication with a longer half life than rofecoxib.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18 -65.
- Patients will be enrolled if they declared that they intended to complete the 25 hour YK fast, and had demonstrated their commitment by doing so for the previous three years (unless medically prevented.)
- We will only enroll patients who stated that they typically suffered from headache during the fast.
Exclusion Criteria:
Patients with chronic medical problems including:
- Heart disease,
- Kidney disease,
- Liver disease,
- Peptic ulcer disease,
- Hypertension,
- Diabetes,
- Lung disease including asthma,
- History of gastrointestinal bleeding,
- Patients with allergies or intolerance in the past to NSAIDs,
- Pregnancy or lactation.
Contacts and Locations| Contact: Zev S Wimpfheimer, MD | 972 50 868 5466 | zevw@hotmail.com |
| Israel | |
| Shaare Zedek Medical Center | Not yet recruiting |
| Jerusalem, Israel, 91031 | |
| Contact: Zev S Wimpfheimer, MD 972 50 868 5466 zevw@hotmail.com | |
| Principal Investigator: | Zev S Wimpfheimer, MD | Shaare Zedek Medical Center, Jerusalem Israel |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Zev Wimpfheimer MD, Shaare Zedek Medical Center, Jerusalem Israel |
| ClinicalTrials.gov Identifier: | NCT00752921 History of Changes |
| Other Study ID Numbers: | 54661.ctil |
| Study First Received: | September 15, 2008 |
| Last Updated: | September 15, 2008 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Shaare Zedek Medical Center:
|
Etoricoxib, Fasting Headache, Headache, Yom Kippur |
Additional relevant MeSH terms:
|
Headache Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Etoricoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013